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Looking for an explanation of a planned deviation

Is there such a thing? I hear this word being thrown around and I was always under the impression a deviation was an unplanned event.

Any insight would be greatly appreciated

Yes there is, for example if do a dry run on a software application and find out during, that one of the tests fails due to a bug in the software.

The bug is explored and the system owner come to the conclusion that it will take about 2 weeks to fit the bug. But a risk assessment is also carried out and it is deemed low impact and does not have any impact on quality.

As a result it is decided to carry on with the validation and document the bug as a deviation. It is not required to state that the bug was known beforehand, this information can remain within the validation team.

Hence the validation is carried out with this known validation.

The deviation is dealt with like any other.

Hope this throws some light on the situation.

I go with, there is no such thing as a “planned deviation.” If an issue is found to a protocol, then the protocol should be revised. Although, there is an issue with changing a protocol to comply with the software. I mean you shouldn’t revise a protocol to make it pass because the software has an issue. That’s where dry runs cause issues. Are you dry running to make the protocol outcome better or to just verify that the testing is feasible.

I agree with you but i have seen cases where stakeholders know of issues but still go ahead and validate.

Planned deviations should not happen as they should be fixed beforehand but they do happen!

So planned deviations do happen and the FDA has no problem with going ahead with a project or other activities if you know of the problem before hand and as long as you justify why it’s ok?

I guess it’s just my feeling that if you know you have an issue before hand, it should be fixed prior to starting. However, I can see it from a business point of view that time is money.

I guess my next question would be, you can have planned deviations as long as you document and justify it and this would be acceptable by the FDA and other outside auditors?

Wait…

I think you have picked me up slightly wrong.

In my experience planned deviations are not documented as planned deviations. It wouldn’t be ok to say to an FDA auditor here is alist of planned deviations we had prior to validation.

Its more of a unwritten rule between the project team members.

A planned deviation is dealt with like any other organic deviation that may occur

Granted I may be new to pharmaceuticals and validation but could you explain what you mean about handling it like any other organic deviation

Basically like any other deviation that may occur without prior knowledge.

To summarize, if you are aware of a deviation before you start the real validation try and fix it, if not carry on and document it as a standard deviation.

Its worth bearing in mind not all companies are the same and each one may handle theri deviation process differently

Hi Guys, Let me write,
The devitions are of two types 1. Planned, 2 . Unplanned.

Let me write about planned deviations, since this is topic of discussion.

The planned deviations are the deviations , which are planned deliberately because of the some circumstances and you may have to suggest the violation of the SOP.
e.g.
As per your SOP , the activity shall be done in XYZ days, However due to unavailability of the resources you will not be able to do the activity in the stipulated time as mentioned in the SOP, so you are deviating the things as mentioned in your SOP. Hence you have to raise the deviation which is planned. .

During the evaluation of the planned deviation , the impact on the quality of the product is accessed ( If the devation is alloved by the authority).and depending on the impact accessed, the devaition is approved or may not be approved.

In unplanned devation, you have already done the deviation unknowingly and the impact is accessed after the deviation.

Anil

I agree with Anil here.

We do occasionally use a “planned deviation” where we intend to contravene a procedure for some reason - as a 1-time event (or if more than 1-time, very limited numbers or timescale).

We raise the same deviation paperwork that we would raise if we contravened the procedure without knowing it; the only difference being that we do not perform an investigation into root cause and perform corrections / corrective actions. Instead we perform a risk assessment to avoid any unintentional consequences arising from the contravention.

One instance where this can be useful is if you intend to trial a new way of performing a proceduralised activity so you can assess whether it is an improvement or not.

However, there is a temptation to use this on inappropriate occasions - so there is a watch out that some checks are in place to stop the occasional “planned deviation” from becoming a new process / practice which is not in accordance with any procedure!

I have to say I’m very pleased with all the information given here. I appreciate it all and I learned a lot. Thanks for all your insights.